Data from the guardian™ clinical trial program support the efficacy and safety of Novoeight®1-3

Bringing well-studied treatments to market is a hallmark of Novo Nordisk. Novoeight® was studied in the guardian clinical trial program—one of the largest clinical trial programs of a recombinant FVIII to date in previously treated patients.1 Results from the trial:

  • Showed zero inhibitors confirmed in 225 previously treated patients who switched to Novoeight®1,a-c
  • Supported the use of Novoeight® for the control and prevention of bleeds, perioperative management, and routine prophylaxis1
  • Showed Novoeight® to be effective in adults, adolescents, and children1-3
Friends living with hemophilia A sitting on the porch


Lino, 27 years old; Lawrence, 19 years old; Blerim, 24 years old; Michael, 30 years old; and Julian, 25 years old, live with hemophilia A.


 



 

guardian™ Clinical Program results1

Novoeight clinical trial results showing inhibitors in 213 treated patients.


 



 

Reliable bleed control2,3

 Charts illustrating bleeds controlled rate for Novoeight patients. Homeostatic success rate is 100%


 



 

Efficacy he can count on

Novoeight clinical trials results.


In initial clinical trials, patients who took Novoeight® had a median of 3.1 bleeds per year.1

Novoeight clinical trials results.


The majority of patients continued in a safety extension trial. Results from an interim analysis showed that patients had a median of 1.6 bleeds per year.4,5,c


ABR=annualized bleeding rate.

aguardian™1: a multicenter, multinational, open-label, single-arm efficacy and safety trial in 150 patients (aged 12 to 65 years) with severe hemophilia A on a prophylactic treatment regimen who were exposed to turoctocog alfa for a mean of 85 exposure days (ranging from 11 to 172 exposure days).2
b
guardian™3: a multicenter, multinational, noncontrolled, open-label safety, efficacy, and pharmacokinetic trial in 63 previously treated pediatric patients (aged 0 to 11 years) with hemophilia A in which patients were exposed to turoctocog alfa for a mean of 60 exposure days (ranging from 20 to 104 exposure days).3
c
guardian™2: a prospective, open-label, uncontrolled extension trial investigating the safety and efficacy of turoctocog alfa in 55 pediatric, 23 adolescent, and 122 adult patients with severe hemophilia A for a mean of 361.6 exposure days. The data cutoff date was December 31, 2013.4,5
d
Patients with previous inhibitors were excluded from the trial. Individuals with hemophilia A may develop inhibitors to FVIII. Monitor patients taking Novoeight® for inhibitor formation.1
eA hemostatic response rated as “excellent” or “good” was considered treatment success. A hemostatic response rated as “moderate” or “none” was considered treatment failure. Missing data were included in the treatment failure category.1-3


 



 

Contact a Novoeight hemophilia therapy sales manager

Talk with us

Connect with a local Novo Nordisk Representative to learn more about Novoeight®. He or she is an excellent source for information, and can direct you to many helpful tools and resources.

 


 



 

Novoeight start guide

Getting him started

Connect to the resources that can help him have a successful start with Novoeight®.

Novoeight MixPro help your patient live an active life.

On the go

With MixPro®, Novoeight® may help your patient keep up with his active lifestyle.


References: 1.
Novoeight® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2014. 2. Lentz SR, Misgav M, Ozelo M, et al. Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013;19(5):691-697. 3. Kulkarni R, Karim FA, Glamocanin S, et al. Results from a large multinational clinical trial (guardian™3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013;19(5):698-705. 4. Data on file, Novo Nordisk Inc.; Plainsboro, NJ. Common technical document summaries (NN001444774), Mar 2013. 5. Lentz, S. R., et al. "Interim results from a large multinational extension trial (guardian™2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A." Haemophilia 22.5 (2016).


 



 

Selected Important Safety Information

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins.

Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment.

Indications and Usage

Novoeight® (Antihemophilic Factor [Recombinant]) is indicated for use in adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Novoeight® is not indicated for the treatment of von Willebrand disease.
 

Important Safety Information

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins.

Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment.

Development of activity-neutralizing antibodies (inhibitors) may occur.  If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration.

The most frequently reported adverse reactions (≥0.5%) were injection site reactions, increased hepatic enzymes, and pyrexia.


Please click here for Novoeight® Prescribing Information.